The Ostomy Files: Ostomy Products are Not Created Equally

   Today's media is replete with stories of litigation involving pharmaceutical company maintenance of patents on brand-name drugs. Like other new products, new drugs are developed under U.S. patent protection - a legal structure that gives a company the sole right to sell a drug while the patent is pending (eg, in effect). After an investment of up to 15 years of research and development and millions (sometimes billions) of dollars spent conducting stringently regulated clinical trials, pharmaceutical companies understandably are eager to recoup their investments in the drug through protection and maintenance of its patent.

   Once a patent expires, competitive manufacturers are free to apply to the Federal Drug Administration (FDA) to sell generic versions of the branded product. This process does not require the generic product manufacturer to repeat costly animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness for the branded product. Therefore, up-front development costs for the generic product are usually substantially lower than they were for the expensive testing required by the FDA previously completed by the original manufacturer.

   Unlike a generic ostomy product, a generic drug is identical, or bioequivalent, to a brand name drug in dosage form, safety, strength, route of administration, quality, performance, characteristics, and intended use. Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price.

   Because medical devices (such as ostomy supplies) and drugs are regulated by different centers within the FDA, their paths to the marketplace are quite different. Medical devices are subject to much less stringent regulations than drugs and are classified according to the degree of regulation needed to provide reasonable assurance of the device's safety and effectiveness and the risk it presents to the user and the patient. Class I medical devices include devices with the lowest risk and Class III includes those with the greatest risk.

   Ostomy supplies and accessories are Class I medical devices and subject to the fewest regulatory controls, which could include registration of the establishment where the device is manufactured, adherence to the FDA's Good Manufacturing Practices (GMP), labeling requirements, and prohibitions against misbranding and adulteration. The FDA does not require evidence of safety and effectiveness before an ostomy product can be marketed. In fact, a substantial percentage of all Class I devices may be marketed without any prior filing with the FDA whatsoever. Clinicians must not assume that ostomy products have been clinically tested for safety and effectiveness before they are marketed. However, some manufacturers conduct such studies and make them available to clinicians and consumers to support their product claims, but the government does not require it.¹

   Typically, large manufacturers have a quality manufacturing system in place that exceeds the FDA's medical device Quality Systems Requirements (QSR). Small manufacturers may or may not have such a system. If one exists, it is usually a proportionally simpler system, so small manufacturers may not need the same amount of documentation as a large manufacturer to meet Class I medical device FDA requirements. Each bit of documentation, research, regulation, or clinical trial adds cost to a product.

   Unlike generic drugs, generic ostomy supplies are not exact equivalents to patent-protected, branded ostomy supplies. Variances are likely in the manufacturing processes, quality, and the composition of skin barrier pastes, powders, and rings, and the thickness of and type of materials used in the pouch. One factor or a combination of factors can lead to differences in wear time and durability. A lower per-unit cost of a generic product can be quickly obliterated by shortened wear times, increases in peristomal skin problems, or even days lost from work due to leakage. Differences also occur in the caliber and variety of value-added services a smaller manufacturer can offer customers as compared to a larger manufacturer. Value-added services are those services provided to customers at no additional charge, such as educational tools, customer service, and other support resources. Once again, clinicians are called upon to evaluate the difference between low per-unit costs and true cost-effectiveness.

   Cost cannot be adequately evaluated today without considering a product's third party reimbursement. FDA approval to market an ostomy product is information the Centers for Medicare and Medicaid Services (CMS) use to decide whether Medicare will cover the product. Clinicians should be aware that FDA approval alone does not translate automatically into Medicare coverage - in fact, FDA marketing clearance does not mean the product will be immediately covered by any public or private third party payer. Each payer has unique coverage guidelines under which ostomy products are covered and paid. Manufacturers often approach insurers to establish coverage and payment before marketing their products.

   Product patents were designed to help manufacturers recapture their initial investment in product development. Costly and drawn out patent litigation drains manufacturers of millions of valuable dollars that could be invested in new and improved product development; this ultimately increases product cost. Practitioners in all clinical settings involved in decision-making about ostomy product recommendations should base their conclusions on sound clinical evidence to support product claims, product effectiveness, and cost and remember that all ostomy products are not created equally.

1. Turnbull GB. The evolution, current status, and regulation of ostomy products in the US. J WOCN 2001;28:18-24.